Senior Clinical Trial Manager

Posted 16 Days Ago
Be an Early Applicant
Blue Bell, PA, USA
In-Office
Expert/Leader
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Manage clinical trial operations for immunology programs including budget oversight, study oversight, developing monitoring plans, training and mentoring CRAs, driving study start-up and enrollment, reviewing trip reports, implementing CAPAs, and fostering relationships with sponsors, vendors, and cross-functional teams.
Summary Generated by Built In
Local Operations Manager - Advanced - Immunology

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


The Sr LTM Immunology will manage and oversee the following throughout the study:

  •  Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.…) including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable.

  •  Execution of local milestones from feasibility through study close out.

  •  Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM).

  •  Inspection Readiness and AQR at the country level.

  •  Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary.

  •  Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence.

  •  Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables.

  •  Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership.

  •  Autonomy with execution of local trial management services

  •  Depth of knowledge with local trial management services

  •  Process leadership

  

What you need to have 

  • BA/BS degree.

  • Degree in a health or science related field.

  • 3 - 5+ years of trial end to end management experience

  • Start-up & Database Locks/Cleaning experience preferred 

  • Immunology trial management experience highly preferred

  • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.

  • Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.

  • Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate

  • To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply

Skills Required

  • Minimum of 4+ years experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization
  • At least 10+ years of relevant experience in clinical trial management
  • Bachelor's degree in health, life sciences, or other relevant field
  • 2+ years of monitoring experience
  • Experience managing complex or global trials
  • Experience managing all trial components from start-up to database lock
  • Experience coaching/mentoring other CTMs, leading a team, and participating in departmental initiatives
  • Willingness to travel as required (approximately 25%)
  • Legal right to work in the country where the role is based

ICON plc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.

  • Healthcare Strength Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
  • Leave & Time Off Breadth Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
  • Retirement Support Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.

ICON plc Insights

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The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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